Table 1 Patient characteristics and treatment response
Clinical characteristics | Evaluable patients, n = 58 |
|---|---|
Age: mean (SD) years | 50.0 (± 9.2) |
Gender | |
Male | 48 (82.8%) |
Female | 10 (17.2%) |
ECOG | |
0 | 25 (43.1%) |
1 to 2 | 33 (56.9%) – 4 patients had ECOG 2 |
Disease stage | |
Metastatic/ recurrent | 33 (56.9%) |
Locoregionally advanced | 25 (43.1%) |
Plasma EBV DNA | |
Baseline (median copies/ml, range) | 23,838 (31–1,924,668) |
Clearance: mean (days, SD) | 24.6 (± 48.6) days |
Clearance: median (days, range) | 10.0 (2.6–322.1) days |
Clearance: ≤ 10 days (patients) | 24 (52.0%)a |
Clearance: > 10 days (patients) | 26 (48.0%)a |
PET response at 4 weeks | |
SUVmax drop: > 50% | 22 (37.9%) |
SUVmax drop: ≤ 50% | 36 (62.1%) |
Dual response: (pEBV DNA and % drop sum of SUVmax of target lesions) | |
≤ 10 days and > 50% drop: yes | 15 (30%) |
≤ 10 days and > 50% drop: no | 35 (70%) |
RECIST (1.1) response at 10 weeks | |
CR | 0 |
PR | 32 (55.2%) |
SD | 22 (37.9%) |
PD | 4 (6.9%) |
Baseline SUVmax and number of lesions selected | Median and range |
Pre-study SUVmax of target lesions | 34.25 (2.5–123.6). |
Number of lesion selected (RECIST) | 5.5 lesions (1–9) |
